- Oracle (Sacramento, CA)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Medtronic (Santa Rosa, CA)
- …profile._ + Bachelor's degree required with a + Minimum of 4 years of experience in medical device regulatory affairs experience + Or Advanced degree ... approval with the agencies. The Sr Regulatory Affairs Specialist is responsible for assessment of device...heart valve products + Experience with Software as a Medical Device + RAC Medical … more
- Meta (Burlingame, CA)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... **Summary:** We're seeking a regulatory affairs specialist to join our medical ...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Cardinal Health (Sacramento, CA)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … more
- GRAIL (Menlo Park, CA)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals. + Effective… more
- Actalent (Lake Forest, CA)
- …Regulatory reporting, Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device , Regulatory affairs , CMC, manufacturing ... Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global...development and sustaining activities. - Strong understanding of global medical device regulations (eg, FDA CFR, EU… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, Regulatory Affairs , Device works with internal and external ... partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for … more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will consider other REGULATED Industry experience + ... focus on regulatory affairs . + 3+ years of related regulatory submission experience from a medical device and/or IVD industry. + Ability to work in a… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Principal Regulatory Affairs Specialist- Shockwave Medical ** to join our team. The ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease… more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site ... glucose levels with our new sensing technology. This **Principal Regulatory Affairs Specialist** position is responsible for...Scientific writing experience. + Solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU)… more
- Abbott (Sylmar, CA)
- …in Mandarin + Previous regulatory compliance, R&D, and/or quality experience in medical device industry + Good working knowledge of the product development ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...Sylmar, CA currently has an opportunity for a Senior Regulatory Affairs Specialist-China. As a Senior … more
- Abbott (Alameda, CA)
- …+ Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at… more
- Abbott (Pleasanton, CA)
- …Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus + ... treatment. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team...+ Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements… more
- J&J Family of Companies (Irvine, CA)
- … Submissions and Assessment Experience **required** . + Experience with Vision related medical device regulatory _highly desired_ . + Working knowledge ... and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …us. **The Associate Director of Regulatory Affairs ** will provide regulatory support for medical device systems within infusion technologies. The ... including at least 5 years in Regulatory Affairs . Must have hands-on experience with complex medical device systems and software, specifically Class II… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge... regulations and/or experience with EU and other international medical device regulations and submissions. + Ability… more
- Abbott (Pleasanton, CA)
- …discipline + 3+ years of related regulatory submission experience from a medical device and/or pharmaceutical industry + Familiar with relevant US/ EU ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...fingersticks. **WHAT YOU'LL DO** We are recruiting for a ** Regulatory Affairs Specialist II** to join our… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …(read, write and speak). + Minimum of 5 years of experience in Regulatory Affairs within the medical device industry, specifically for Class II and/or ... of possible** with us. **Job Summary** The Senior Specialist, Regulatory Affairs plays a key role in...+ Strong understanding of China, Hong Kong and Taiwan medical device regulations. + Demonstrated experience in… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …become your best self. Become a **maker of possible** with us. Director of Regulatory Affairs is responsible for developing and implementing regulatory ... with US and international laws and regulations + Manage Regulatory Affairs platform and leads a team...the site and functional level + Ability to interpret medical device testing methods and statistics, as… more